Statement_of_Work_Attachment.pdf

Statement of Work Electronic Health Record

Attachment 1

The Food and Drug Administration (FDA)/National Center for Toxicological Research (NCTR)/Division of Bioinformatics and Biostatistics (DBB) is conducting research to assess the disparities on drug-host interaction of drug-induced liver injury (DILI) reported in large electronic medical record (EMR) systems using advanced methodologies for minority populations.

The DBB requires use of the EMR database developed by the U.S. Department of Veterans Affairs (VA) Informatics and Computing Infrastructure (VINCI) to investigate human DILI, including over 100 drugs which are known to cause DILI in humans. In this database, relevant clinical data of DILI cases and controls are aggregated as a relational database. The database contains data from approx. 5.9 million unique veterans who are seen in a given fiscal year.

Data Required Includes:

• Drug dictionary

• Laboratory dictionary

• ICD-9 dictionary

• Patients receiving any of the Study drugs

• Patients with DILI

• Exclude other cases of acute liver injury

• Medication-matched control population database

• Study population table and liver event tables

• Patient demographic table

• Comedications taken at time-of DILI events

• Database of comorbidities at DILI events

• Model implementation

• Provide aggregated data in the form of PDF, MS Word, MS Excel files, or text files as applicable

Specific Study Aims:

• A Bayesian approach known as topic modeling will be employed to discover the underlying semantic structure of textual data in the FDA Adverse Event Reporting System (FAERS), Vigibase and the VA Electronic Health Record (HER) surveillance databases

• The topic model will allow indexing by drug, ethnicity and gender to structure findings in a relational format to deploy in a web-based tool

• The FDA public health mission is enhanced because the data will be organized in such a manner to foster efficient dissemination of information to affected minority populations, who are underserved and may otherwise lack of access to safety information.

Any ensuing Contract shall have a Period of Performance consisting of a Base Period for 1-Year (365 Days), with an option for an additional 1-year Period of Performance.